Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511804
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Patients
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mespere ICP
Brief Summary:
The purpose of this clinical research project is to employ Mespere LifeSciences NeurOs Cerebral Oximetry system equipped with noninvasive sensors approved by the FDA to monitor and investigate the correlation within a cohort of patients suffering from traumatic brain injury TBI stroke brain tumor and brain bleeding This study aims to investigate and establish the correlation between blood vessel functionality parameters-specifically VasodilationConstriction Index VDC Vascular Resistance Index VR and Volume Reactivity Index VRx-with the crucial physiological indicators Intracranial Pressure ICP and Mean Arterial Pressure MAP By doing so the investigators seek to address fundamental questions surrounding cerebral hemodynamics and autoregulation in various neurological conditions
Detailed Description:
For this research the investigators will strategically position two noninvasive sensors on the patients foreheads specifically over the temporal region It is imperative that the skin in this area is accessible free from hair or any underlying wounds beneath the sensor These sensors are specifically designed to gather crucial data on cerebral oxygen saturation StO2 and blood volume index BVI As per FDA recommendations should the monitoring extend beyond 6 hours it is advisable to replace the sensor adhesive to ensure optimal functionality and accuracy The collected information will be transmitted to the investigators monitoring system equipped with preinstalled software that offers real-time insights into several key parameters
1 Regional Tissue Oxygen Saturation StO2 This parameter provides data on regional hemoglobin oxygen saturation in the cerebral tissue beneath the sensor It is captured using our cerebral oximetry sensors and offers critical insights into tissue oxygenation
2 Blood Volume Index BVI BVI provides information on the regional blood-to-tissue volume ratio in the cerebral tissue beneath the sensor again captured using our cerebral oximetry sensors BVI is instrumental in understanding blood volume dynamics in the brain
3 Mean Arterial Pressure MAP and Systolic Blood Pressure SBP Real-time MAP and SBP data will be pulled from the Philips patient monitor providing a comprehensive overview of the patients circulatory status
4 Intracranial Pressure ICP Similar to MAP and SBP real-time ICP data will also be pulled from the Philips patient monitor offering valuable insights into intracranial dynamics
5 VasodilationConstriction Index VDC VDC is a derived parameter from BVI signifying the relative change in blood vessel cross-sectional area An increase indicates vessel dilation while a decrease indicates vessel constriction This index offers insights into cerebral vessel reactivity
6 Vascular Resistance Index VR VR is a derived parameter from BVI indicating the percent change in blood vessel resistance based on the Hagen-Poiseuille formula VR helps assess the resistance to blood flow within cerebral vessels
7 Volume Reactivity Index VRx VRx is a real-time moving Pearson Correlation Coefficient between Blood Volume Index BVI derived from our Cerebral Oximetry sensors and MAP This parameter is derived from Pressure Reactivity Index PRx making VRx a non-invasive alternative to the invasive PRx VRx is used to assess autoregulation
1 Regional Tissue Oxygen Saturation StO2 This parameter provides data on regional hemoglobin oxygen saturation in the cerebral tissue beneath the sensor It is captured using our cerebral oximetry sensors and offers critical insights into tissue oxygenation
2 Blood Volume Index BVI BVI provides information on the regional blood-to-tissue volume ratio in the cerebral tissue beneath the sensor again captured using our cerebral oximetry sensors BVI is instrumental in understanding blood volume dynamics in the brain
3 Mean Arterial Pressure MAP and Systolic Blood Pressure SBP Real-time MAP and SBP data will be pulled from the Philips patient monitor providing a comprehensive overview of the patients circulatory status
4 Intracranial Pressure ICP Similar to MAP and SBP real-time ICP data will also be pulled from the Philips patient monitor offering valuable insights into intracranial dynamics
5 VasodilationConstriction Index VDC VDC is a derived parameter from BVI signifying the relative change in blood vessel cross-sectional area An increase indicates vessel dilation while a decrease indicates vessel constriction This index offers insights into cerebral vessel reactivity
6 Vascular Resistance Index VR VR is a derived parameter from BVI indicating the percent change in blood vessel resistance based on the Hagen-Poiseuille formula VR helps assess the resistance to blood flow within cerebral vessels
7 Volume Reactivity Index VRx VRx is a real-time moving Pearson Correlation Coefficient between Blood Volume Index BVI derived from our Cerebral Oximetry sensors and MAP This parameter is derived from Pressure Reactivity Index PRx making VRx a non-invasive alternative to the invasive PRx VRx is used to assess autoregulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None